JP6382808B2 - 反転型の経カテーテル的弁とその方法 - Google Patents
反転型の経カテーテル的弁とその方法 Download PDFInfo
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- JP6382808B2 JP6382808B2 JP2015524278A JP2015524278A JP6382808B2 JP 6382808 B2 JP6382808 B2 JP 6382808B2 JP 2015524278 A JP2015524278 A JP 2015524278A JP 2015524278 A JP2015524278 A JP 2015524278A JP 6382808 B2 JP6382808 B2 JP 6382808B2
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Images
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Description
本出願は、2012年7月25日付けで出願された仮出願第61/675,744号に基づく優先権を主張し、この仮出願の全体が本明細書中に参照として援用される。
図1Aと図1Bは、それぞれに、実施形態による非反転形態と反転形態との側面図である。図1Cは図1Bの実施形態の斜視図である。図2は、弁100が長手方向に切断されており且つ概ね管状の形態の弁100の要素をより適切に示すために展開された状態にある、図1の実施形態を示す。図3Aと図3Bは、それぞれに、開放形態と閉鎖形態の形である、弁100の軸方向図である。弁100は、本体フレーム120と、リーフレットフレーム130と、本体フレーム120とリーフレットフレーム130とを覆い且つ本体フレーム120をリーフレットフレーム130に連結し且つリーフレット140を形成するフィルム160を備える。
フィルム160は、概して、生体適合性であり且つ本体フレーム120及びリーフレットフレーム130に連結するように構成されている任意のシート状の材料である。リーフレット140もフィルム160によって構成されている。フィルム160は、一般的に、特定の目的に適している1つ又は複数の生体適合性の材料のために使用されるということを理解されたい。さらに、本体フレーム120に連結されているフィルム160が、リーフレットフレーム130に連結されている同一のフィルム160ではないことがあるということも理解されたい。様々なタイプのフィルムの詳細が後述されている。一実施形態では、フィルム160は、本体フレーム120とリーフレットフレーム130とを少なくとも部分的に覆うために、概ね管状の材料から形成されているだろう。このフィルム160は、膜、複合材料、又は、積層物の1つ又は複数を含むことが可能である。様々なタイプのフィルム160の詳細が後述されている。
本体フレーム120は、図1Aと図1Cと図3Aとに示されている、本体フレーム内側表面129を有する本体フレーム管腔123を形成する概ね管状の部材である。本体フレーム120は、異なる直径の間で本体フレーム120が圧縮及び拡張されることを可能にすることが可能な、概ね開いた穴のパターン122を形成する。本体フレーム120は、ステントとして当業で知られている構造を備えることがある。ステントは、解剖学的組織の中への経皮的で経カテーテル的な送達に適している小さい直径を有し、且つ、解剖学的組織の中に配置される時に、より大きい直径に拡張されることが可能な、管状部材である。様々なデザインと材料特性を有するステントが当業者に公知である。
リーフレットフレーム130は、図1Aと図2に示されている、予め決められた反復パターンを形成する概ね環状の部材を備える。リーフレットフレーム130は、ワイヤ、リボン、切断チューブ(cut tube)、又は、この特定の目的に適している他の任意の要素を含むだろう。図2に示されているように、リーフレットフレーム130は、互いに連結した3つのU字形部分132を備える。このU字形部分132の各々は、基部134を形成する2つの側部133を形成し、及び、側部133の各々は自由端部135を有する。この実施形態では、基部134は、さらに詳細に後述する屈曲点136を形成する。1つのU字形部分132の自由端部135は、支柱131を形成する隣のU字形部分132の自由端部135と相互連結させられる。
リーフレット130のU字形部分132の各々が、内側領域137を形成する。各々の内側領域137は、フィルム160等の生体適合性材料を備えており、この生体適合性材料は、リーフレットフレーム130の側部133と基部134に連結されており、及び、フィルム160はリーフレット140を形成する。各々のリーフレット140はリーフレット自由端縁142を形成する。
図1Aに示されているように、本体フレーム120は、リーフレットフレーム130に横方向に隣接して且つリーフレットフレーム130から間隔を開けて同軸的に位置しており、及び、図2に示されているように、弁100の巻き解された図においては、リーフレットフレーム130と同一平面上に位置している。U字形部分132の基部134は、本体フレーム120の第1の本体フレーム端部127に隣接して配置されており、及び、リーフレットフレーム130のU字形部分132は本体フレーム120から離れる形で延びる。本体フレーム120とリーフレットフレーム130との間の空間が、フィルム160と架橋される時に、弁100の折り目領域144を形成する。弁100は、さらに、本体フレーム120とリーフレットフレーム130とに連結されているフィルム160を備え、このフィルム160は、少なくとも折り目領域144にまたがって、本体フレーム120をリーフレットフレーム130に連結する。後述するように、反転した形態では、フィルム160は、折り目領域144内で概ね円周線146に沿って折り曲げられている。折り目領域144内のフィルム160は、リーフレットフレーム130がそのヒンジを中心に本体フレーム120の中に反転することが可能なヒンジを実現する。
図1Aに示されているように、非反転形態では、リーフレットフレーム130は、本体フレーム120と同軸的に配置されており、及び、本体フレーム120から離れて延びる。反転形態の形では、リーフレットフレーム130は、図3Cに示されているように、本体フレーム120と同軸であることを維持しながら本体フレーム120の中に配置されるように、折り目領域144の周りで折り曲げることによって、本体フレーム120内に反転させられている。非反転形態から反転形態への移行は、一般的に配置時点において、生体内原位置において、血管内で行われるだろう。
一実施形態では、リーフレットフレーム130が本体フレーム120の中に反転させされた後に、リーフレットフレーム130は、最終的な作動形態を実現するために本体フレームの内側表面129に対して押し付けられるだろう。一実施形態では、リーフレットフレーム130は反転形態に向かうばね偏倚を有し、リーフレットフレーム130は偏倚された付勢係合(biased urging engagement)の形で本体フレーム120に係合する。
一実施形態では、1つ又は複数のクラスプ(図示されていない)又は幾つかの他の同様の係合機構が、支柱131を本体フレーム120に固定し、及び、予め決められた量の構造的剛性をリーフレットフレーム130に付与することが可能である。したがって、リーフレットフレーム130上の力が、少なくとも部分的に、本体フレーム120に伝達又は分配されるだろう。この点で、クラスプは、リーフレットフレーム130と本体フレーム120とを相互固着するか、互いに連結するか、互いに締め付け固定するか、又は他の形で一体状に保持するための任意の構造を備える。リーフレットフレーム130を本体フレーム120に連結するクラスプは、リーフレットフレーム130上の力の少なくとも一部分を本体フレーム120に伝達する働きをする。
リーフレット140を形成する生体適合性材料が、生物組織、又は、生体適合性ポリマー等の充分に適合的で可撓性である合成生体適合性材料を含むことが可能である。一実施形態では、リーフレット140は、複合材料と呼ばれる、エラストマーと組み合わされている生体適合性ポリマーを含む。一実施形態による材料は、フィブリルのマトリックス内に複数の空間を有する延伸フルオロポリマー膜と、エラストマー材料とを含む複合材料を含む。本開示の範囲内において、多様なタイプのフルオロポリマー膜と多様なタイプのエラストマー材料とが、積層物を形成するために組み合わされることが可能であるということを理解されたい。さらに、このエラストマー材料は、本開示の範囲内において、多様なエラストマーと、多様なタイプの非エラストマー性成分(例えば、無機充填材、治療薬剤、放射線不透過性マーカー、又は、これらと同種のもの)を含むことが可能であるということを理解されたい。
一実施形態では、弁100は、大動脈弁置換処置で遭遇することがあるように、移植される時に左心室内の索枝を覆わないことによって、心臓刺激伝導系への干渉を防止するように構成されることが可能である。例えば、弁100は、約25mm未満の長さ、又は、約18mm未満の長さを有することが可能である。弁100は、さらに、1未満の縦横比を有することが可能であり、この場合に、この縦横比は、弁100の長さと拡張された機能的直径との間の関係を表す。しかし、弁100は、任意の長さに、及び、さらに一般的には、任意の所望の寸法に、構成されることが可能である。
一実施形態では、図4と図5A−5Cとを参照すると、弁送達システム500が、上述した折り畳み形態と拡張形態とを有する弁100と、弁100を血管内において配置するように構成されているバルーンカテーテル等の細長い可撓性のカテーテル480とを備える。カテーテル480は、弁100を拡張するための、及び/又は、必要に応じて、適切な固定を確実なものにするように弁100を修正するための、バルーンを備えることが可能である。弁100は、脈管構造の中を通した送達のためにカテーテル480の遠位部分に取り付けられることが可能である。カテーテル480上に折り畳み形態で弁を保持するために、弁送達システムは、さらに、経カテーテル的弁(transcatheter valve)100上に密接的にぴったりと被さる取り外し可能なシース(theath)482を備えることもある。
弁100の実施形態が、経カテーテル的方法を使用するのではなく、外科的に移植されてもよいということを理解されたい。外科的に移植された弁100の実施形態は、一実施形態による本体フレームの外側表面127の周りの縫合カフ(sewing cuff)を付加することを伴うが、上述した実施形態と実質的に同一だろう。当業で公知の縫合カフは、組織開口部等の移植部位に弁100を連結するための縫合糸を受け入れる構造を提供する働きをする。縫合カフは、非限定的に例えば二重ベロアポリエステル(double velour polyester)等の、任意の適切な材料を含むだろう。縫合カフは、基部フレームに応じて、本体フレーム120の周りに円周方向に配置されるか、又は、弁周囲に配置されるだろう。リーフレットフレーム130は、本体フレーム120が移植部位に固定される前に、又は、固定された後に、本体フレーム120の中に反転させられるだろう。
本明細書で説明されている実施形態は、さらに、本明細書で説明されている弁の実施形態を作成する方法にも関する。様々な実施形態を作成するために、巻線治具(winding jig)と2部品型リーフレットマンドレルとが使用されることが可能である。図6を参照すると、巻線治具590は、弁の弁開口部を形成する構造的形状と、所望のリーフレットフレーム形状の形にワイヤを形成することを容易化するように構成されているリーフレットフレームガイド591とを有する。図8A−8Bを参照すると、2部品型マンドレル595は、リーフレットを形成するために管状の膜又は複合材料を成形するようにマンドレルを一体的に形成する、リーフレットクランプ596と基部型(base mold)597とを備える。リーフレットクランプ596は、リーフレットフレーム130に所望の湾曲又は屈曲を形成するために支柱131が中に配置される、リーフレットクランプ596の継ぎ目に沿った輪郭形成溝(contoured groove)594を備える。
一例として、反転可能な弁の一実施形態が次のように作成されることが可能である。
特定の方法及び機器が以下で説明されているが、当業者によって適切であると判断される任意の方法及び機器が代替策として使用されてもよいということを理解されたい。
泡立ち点及び平均流動気孔径(mean flow pore size)を、ASTM F31 6−03の全般的な教示に従って、Capillary Flow Porometer、Model CFP 1500AEXL(Porous Materials,Inc.,Ithaca,NY,USA)を使用して測定した。このサンプル膜をサンプルチャンバー内に配置し、20.1ダイン/cmの表面張力を有するSilWick Silicone Fluid (Porous Materials Inc.より入手可能)で濡らした。このサンプルチャンバーの底部クランプは直径2.54cmの穴を有した。試験流体はイソプロピルアルコールだった。Capwinソフトウェア バージョン7.73.012を用いて、以下のパラメータを下記の表に指定されている通りに設定した。本明細書では、平均流動気孔径と気孔径は互換的に使用されている。
パラメータ 設定値
Maxflow(cm3/m) 200000
Bublflow(cm3/m) 100
F/PT(old bubltime) 50
Minbpres(PSI) 0
Zerotime(sec) 1
V2incr(cts) 10
Preginc(cts) 1
Pulse delay(sec) 2
Maxpre(PSI) 500
Pulse width(sec) 0.2
Mineqtime(sec) 30
Presslew(cts) 10
Flowslew(cts) 50
Eqiter 3
Aveiter 20
Maxpdif(PSI) 0.1
Maxfdif(PSI) 50
Sartp(PSI) 1
Sartf(cm3/m) 500
細孔内のエラストマーの存在が、表面及び/又は横断面の画像、又は、他の分析等の、当業者に公知の幾つかの方法で判定されることが可能である。この分析は、複合材料からのエラストマーの除去の前と後に行われることが可能である。
フィブリルの平均直径が、図9A−9Cの走査電子顕微鏡検査(SEM)顕微鏡写真等の、多数のフィブリルを示すために適している倍率を有する得られた顕微鏡写真を検査することによって推定された。複合材料の場合には、フィブリルを露出させるために、任意の適切な手段によって、細孔を満たしている可能性があるエラストマー又は他の材料を取り出すことが必要だろう。
膜厚さが、Kaefer FZ1000/30厚さ挟みゲージ(Kaefer Messuhrenfabrik GmbH,Villingen−Schwenningen,Germany)の2つのプレートの間に膜を置くことによって測定された。3つの測定値の平均が報告された。
ρ=m/(w*l*t)
を使用して密度が計算され、前式中で、ρ=密度(g/cm3)、m=質量(g)、w=幅(cm)、l=長さ(cm)、及び、t=厚さ(cm)である。3つの測定値の平均が報告された。
引張破断荷重(tensile break load)を、平面グリップ(flat−faced grip)と0.445kNロードセルとを備えたINSTRON 122引張試験装置を使用して測定した。ゲージ長さは約5.08cmであり、及び、クロスヘッド速度は約50.8cm/分だった。サンプル寸法が約2.54cm×約15.24cmだった。最大強度測定のために、サンプルのより長い方の寸法(longer dimension)を最大強度方向に方向配置した。直交MTS測定のために、サンプルのより大きい方の寸法(larger dimension)を最大強度方向に対して垂直に方向配置した。各々のサンプルを、Mettler Toledo Scale Model AG204を使用して重量測定し、その次に、厚さをKaefer FZ1000/30挟みゲージを使用して測定し、あるいは、この代わりに、厚さ測定のための任意の適切な手段を使用してもよい。その次に、サンプルを、引張試験機上で個別的に試験した。各サンプルの3つの異なる部分を測定した。3つの最大荷重(即ち、最大負荷)測定値の平均が報告された。長手方向及び横断方向のマトリックス引張強度(MTS)を、次式
MTS=(最大荷重/横断面積)*(PTFEの嵩密度)/(多孔性膜の密度)
を使用して計算し、前式中で、PTFEの嵩密度を約2.2g/cm3であるように選んだ。
Claims (53)
- 経カテーテル的弁において、
本体フレーム管腔を形成する概ね環状の形状を有する本体フレームと、
基部と複数の支柱とを各々が形成する複数のU字形部分を形成する概ね環状の形状を有するリーフレットフレームであって、前記本体フレームは、前記リーフレットフレームに隣接して、且つ、前記リーフレットフレームから間隔を置いて、同軸的に延び、前記U字形部分の各々の前記基部は、前記本体フレームの第1の本体フレーム端部の付近に且つ前記第1の本体フレーム端部に対して非接触状態に配置されており、前記リーフレットフレームの前記U字形部分は前記本体フレームから離れて延び、且つ、前記支柱は前記本体フレームから離れて延び、及び、前記支柱は、前記第1の本体フレーム端部から遠位にあるリーフレットフレームと、
フィルムであって、前記フィルムは、前記U字形部分と前記本体フレームとの間を端から端まで延び、及び、前記本体フレームと前記リーフレットフレームとの間を延びる前記フィルムは折り目領域を形成し、前記U字形部分の各々の間を延びる前記フィルムはリーフレットを形成し、及び、前記リーフレットフレームは、前記リーフレットフレームが少なくとも部分的に前記本体フレーム管腔の内側に少なくとも部分的に同軸的に配置される位置に前記折り目領域を中心に回転することによって反転位置に反転する働きをし、及び、前記リーフレットの各々は開放位置と閉鎖位置との間を移動可能であるフィルムとを備える経カテーテル的弁。 - 前記フィルムは前記本体フレームと前記リーフレットフレームとをサンドイッチする請求項1に記載の経カテーテル的弁。
- 前記リーフレットはポリマー材料を含む請求項1に記載の経カテーテル的弁。
- 前記リーフレットは積層物を含む請求項3に記載の経カテーテル的弁。
- 前記積層物は、フルオロポリマー膜の3つ以上の層を有する請求項4に記載の経カテーテル的弁。
- 前記リーフレットは、複数の細孔を有する少なくとも1つのフルオロポリマー膜の層と、フルオロポリマー膜の少なくとも1つの層の細孔の実質的にすべての中に存在するエラストマーとを有する、複合材料を含む請求項4に記載の経カテーテル的弁。
- 前記複合材料は約10重量%から約80重量%のフルオロポリマー膜を含む請求項6に記載の経カテーテル的弁。
- 前記エラストマーは(パー)フルオロアルキルビニルエーテル(PAVE)を含む請求項6に記載の経カテーテル的弁。
- 前記エラストマーは、テトラフルオロエチレンとパーフルオロメチルビニルエーテルとのコポリマーを含む請求項6に記載の経カテーテル的弁。
- 前記フルオロポリマー膜はePTFEを含む請求項6に記載の経カテーテル的弁。
- 前記本体フレームは非形状記憶材料を含む請求項1に記載の経カテーテル的弁。
- 前記本体フレームは、前記本体フレームが折り畳み輪郭に圧縮されることと異なる直径の間で拡張されることとを可能にする働きをする、概ね開いた穴のパターンを形成する概ね管状の部材である請求項1に記載の経カテーテル的弁。
- 経カテーテル的弁送達システムにおいて、
送達カテーテルと、
経カテーテル的弁であって、
本体フレーム管腔を形成する概ね管状の形状を有する本体フレームと、
基部と複数の支柱とを各々が形成する複数のU字形部分を形成する概ね環状の形状を有するリーフレットフレームであって、前記本体フレームは、前記リーフレットフレームに隣接して、且つ、前記リーフレットフレームから間隔を置いて同軸的に延び、及び、前記U字形部分各々の前記基部は、前記本体フレームの第1の本体フレーム端部の付近に且つ前記第1の本体フレーム端部に対して非接触状態で配置されており、前記リーフレットフレームの前記U字形部分は前記本体フレームから離れて延び、及び、前記支柱は前記本体フレームから離れて延び、及び、前記支柱は、第1の本体フレーム端部から遠位にあるリーフレットフレームと、
フィルムであって、前記フィルムは前記U字形部分と前記本体フレームとの間を端から端まで延び、及び、前記本体フレームと前記リーフレットフレームとの間を延びる前記フィルムは折り目領域を形成し、及び、前記U字形部分の各々の間を延びる前記フィルムはリーフレットを形成し、及び、前記リーフレットフレームは、前記リーフレットフレームが少なくとも部分的に前記本体フレーム管腔の内側に少なくとも部分的に同軸的に配置される位置に前記折り目領域を中心に回転することによって反転位置に反転する働きをし、及び、前記リーフレットの各々は開放位置と閉鎖位置との間を移動可能である、フィルムとを備え、
前記経カテーテル的弁は、反転形態と非反転形態とを備え、及び、前記送達カテーテルは、前記経カテーテル的弁を移植部位に前進させる働きをする、経カテーテル弁とを備える経カテーテル的弁送達システム。 - 前記送達カテーテルは、圧縮形態から拡張形態への前記経カテーテル的弁の拡張を容易化する働きをする請求項13に記載の経カテーテル的弁送達システム。
- 前記送達カテーテルはバルーンを備える請求項14に記載の経カテーテル的弁送達システム。
- 前記送達カテーテルは、前記経カテーテル的弁の上にぴったりと被さり且つ前記経カテーテル的弁を圧縮形態に保持するための取り外し自在なシースを備える請求項14に記載の経カテーテル的弁送達システム。
- 前記経カテーテル的弁は反転形態と非反転形態とを備える請求項13に記載の経カテーテル的弁送達システム。
- 前記経カテーテル的弁は前記非反転形態で送達される請求項17に記載の経カテーテル的弁送達システム。
- 前記経カテーテル的弁の前記本体フレーム管腔の中に前記リーフレットフレームを反転させる働きをする反転装置をさらに備える請求項18に記載の経カテーテル的弁送達システム。
- 前記本体フレームは、前記リーフレットフレームよりも硬質である請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットはポリマー材料を含む請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットは、2つ以上のフルオロポリマー膜を有する積層物を含む請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットは、エラストマー層を有する積層物を含む請求項22に記載の経カテーテル的弁送達システム。
- 前記リーフレットは、複数の細孔を有する少なくとも1つのフルオロポリマー膜の層と、少なくとも1つのフルオロポリマー膜の層の前記細孔の実質的にすべての中に存在するエラストマーとを有する、複合材料を含む請求項22に記載の経カテーテル的弁送達システム。
- 前記複合材料は、約10重量%から約90重量%のフルオロポリマー膜を含む請求項24に記載の経カテーテル的弁。
- 前記エラストマーは(パー)フルオロアルキルビニルエーテル(PAVE)を含む請求項25に記載の経カテーテル的弁送達システム。
- 前記エラストマーは、テトラフルオロエチレンとパーフルオロメチルビニルエーテルとの熱可塑性コポリマーを含む請求項25に記載の経カテーテル的弁送達システム。
- 前記フルオロポリマー膜はePTFEを含む請求項22に記載の経カテーテル的弁送達システム。
- 前記本体フレームは非形状記憶材料を含む請求項13に記載の経カテーテル的弁送達システム。
- 前記本体フレームは、中心軸線に対して垂直な平面に関して実質的に対称的である請求項13に記載の経カテーテル的弁送達システム。
- 前記本体フレームは開放フレームワークを備える請求項13に記載の経カテーテル的弁送達システム。
- 前記本体フレームは実質的に軸方向に硬質である請求項13に記載の経カテーテル的弁送達システム。
- 前記経カテーテル的弁の拡張された直径に対する前記経カテーテル的弁の長さの縦横比が1未満である請求項13に記載の経カテーテル的弁送達システム。
- 前記本体フレームの長さは約20mm未満である請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットフレームは、中心軸線に対して垂直な平面に関して実質的に非対称的である請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットフレームは形状記憶材料を含む請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットフレームは金属材料を含む請求項13に記載の経カテーテル的弁送達システム。
- 前記リーフレットフレームはワイヤで形成されている請求項13に記載の経カテーテル的弁送達システム。
- 前記折り畳み形態は、6mm未満の折り畳み直径を有する請求項13に記載の経カテーテル的弁送達システム。
- 前記経カテーテル的弁はバルーン拡張型である請求項13に記載の経カテーテル的弁送達システム。
- 経カテーテル的弁において、
概ね管状の形状を形成する本体フレームと、
概ね環状の形状を形成するリーフレットフレームであって、その間に折り目領域を形成する本体フレームに対して同軸的に配置されており、且つ、前記本体フレームから離れて且つ間隔を置いて延び、及び、前記リーフレットフレームは、基部と複数の支柱とを各々が形成する複数のU字形部分を形成し、及び、前記U字形部分各々の前記基部は、前記本体フレームの第1の本体フレーム端部の付近に且つ前記第1の本体フレーム端部に対して非接触状態で配置されており、及び、前記リーフレットフレームの前記U字形部分は前記本体フレームから離れて延び、及び、前記支柱は前記本体フレームから離れて延び、及び、前記支柱は、前記第1の本体フレーム端部から遠位にあるリーフレットフレームと、
前記本体フレームと前記リーフレットフレームとの間を端から端まで延び、前記折り目領域を架橋し、且つ、前記本体フレームを前記リーフレットフレームに連結するフィルムであって、前記リーフレットフレームと前記フィルムは、各々の前記U字形部分内に配置されている複数のリーフレットを形成し、前記リーフレットの各々はリーフレット自由端縁を有し、及び、前記リーフレットフレームは、前記リーフレットフレームを前記本体フレームの内側に少なくとも部分的に配置するように前記折り目領域に沿って反転する働きをし、前記リーフレットフレームは、前記リーフレット自由端縁が隣接するリーフレット自由端縁に当接し且つ開放位置と閉鎖位置との間を移動可能である弁を形成する、フィルムとを備える経カテーテル的弁。 - 前記本体フレームは前記リーフレットフレームよりも硬質であり、
前記フィルムはポリマー材料を含む請求項41に記載の経カテーテル的弁。 - 前記フィルムは積層物を含む請求項42に記載の経カテーテル的弁。
- 前記積層物はフルオロポリマー膜の2つ以上の層を有する請求項43に記載の経カテーテル的弁。
- 前記フィルムは、複数の細孔を有する少なくとも1つのフルオロポリマー膜の層と、少なくとも1つのフルオロポリマー膜の層の前記細孔の実質的にすべての中に存在するエラストマーとを有する、複合材料を含む請求項42に記載の経カテーテル的弁。
- 前記複合材料は約80重量%未満のフルオロポリマー膜を含む請求項45に記載の経カテーテル的弁。
- 前記エラストマーは(パー)フルオロアルキルビニルエーテル(PAVE)を含む請求項45に記載の経カテーテル的弁。
- 前記エラストマーは、テトラフルオロエチレンとパーフルオロメチルビニルエーテルとのコポリマーを含む請求項45に記載の経カテーテル的弁。
- 前記フルオロポリマー膜はePTFEを含む請求項45に記載の経カテーテル的弁。
- 前記本体フレームは前記リーフレットフレームよりも硬質であり、
前記本体フレームは、前記本体フレームが折り畳み形態に圧縮されることと異なる直径の間で拡張されることとを可能にする働きをする開放フレームワークを備え、
前記本体フレームは、前記本体フレームが異なる直径の間で圧縮及び拡張されることを可能にする働きをする概ね開いた穴のパターンを形成する概ね管状の部材である請求項41に記載の経カテーテル的弁。 - 前記本体フレームは前記リーフレットフレームよりも硬質であり、前記リーフレットフレームは形状記憶材料を含む請求項41に記載の経カテーテル的弁。
- 前記本体フレームは前記リーフレットフレームよりも硬質であり、前記リーフレットフレームは金属材料を含む請求項41に記載の経カテーテル的弁。
- 前記本体フレームは前記リーフレットフレームよりも硬質であり、前記リーフレットフレームはワイヤで形成されている請求項41に記載の経カテーテル的弁。
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